[Press Release, May 18, 2020 / unofficial translation] One-stop Support with a Product Manager, from Drug Development to Marketing - Expanding the role of Product Manager (PM) from ‘the support for development/approval stages’ to ‘life-cycle management’ - □ In order to increase the predictability of approval and examination processes and professionalism of safety management, the Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) expands the role of Product Managers, which has been limited to the drug approval to the whole life-cycle of the process from drug development to post-market, thereby transforming into a one-stop support/management system. ○ Accordingly, Product Managers, newly made in 2009, will supervise and manage the whole life-cycle of the process, including preliminary examination of development, re-examination after approval, and risk management, not just limited to the existing drug approval and examination management. - For reference, advanced drug regulatory authorities such as in the USA and Europe also operate Product Manager systems, and the scope of the managers’ role has been expanding. ※ Product Manager (PM): A supervisor of drugs at the Ministry of Food and Drug Safety who manages the history of the whole life-cycle process such as approval and examination, operates communication channels between examiners and developers and recognizes the problems at an early stage to thereby enhancing the efficiency and predictability of approvals. □ Product Managers will be supervised by the Ministry of Food and Drug Safety headquarters, and the Ministry plans to apply differential management systems by categorizing new drugs and orphan drugs or products with a high level of risk as ‘specially managed products’ and assigning personnel with a high level of expertise and experience to the products. ○ Pharmaceutical businesses can receive consultations needed from the drug development stage to the post-market stage through the designated Product Manager, and the information about applicable Product Managers is available on the Ministry of Food and Drug Safety’s website. ※ Ministry’s website > About MFDS > Search Employees > Refer to the duties of ‘Pharmaceutical Approval Management Team’ (only in Korean) □ Minister Lee Eui-Kyung stated that the Ministry will work hard to settle down the policies in an early stage since an expansion of the roles of Product Managers is a policy we are propelling with a strong will for the Ministry of Food and Drug Safety to leap forward as a world-class regulatory authority, and also announced that ○ the Ministry will support the quick development of effective medical products, communicate with professionals such as doctors and pharmacists while creating an environment for the public to use the products at ease.